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510(k) K823388

TENS MAX by Fujisawa Electronics Co. — Product Code GFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1983
Date Received
November 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen Determination Standards And Controls
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type